Medical Device Registration and Approval in Italy
General country-specific regulatory information is provided on this page for medical device registration and approval in Italy.
Last updated on November 29th, 2021.
Medical Device Regulations and Classification in Italy
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Italy, devices are regulated by the Ministry of Health Directorate General for Medicines and Medical Devices using the National Health Information System (NSIS).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the EU.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
Any Medical or IVD device that is to be sold in Italy must be registered with the Italian NSIS Database.
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